Attention Deficit Disorder With HyperactivityPhase 4B-MPHNCT00257725
Long-Duration Stimulant Treatment Study of ADHD in Young Children
A Phase 4 study testing B-MPH in people with Attention Deficit Disorder With Hyperactivity, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- B-MPH
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents/guardians and children must speak English and/or Spanish; parents/guardians must sign consent form; children must verbally assent.
- Boys and girls from 4-5 years old (inclusive) at screening.
- Children who meet the DSM-IV criteria for a primary diagnosis of ADHD (combined or hyperactive subtype), with symptoms present for at least 9 months.
- Children who demonstrate adequate need for treatment due to ADHD symptom-severity and clinical impairment.
- Children with IQ of at least 70 confirmed by valid IQ test.
- Children who are in educational settings (pre-school, kindergarten, or elementary school program) with at least 8 same-age peers for at least two half days weekly.
- Parents and children who can attend weekly study visits.
- Children who are naïve to ADHD medications; received ADHD medications in the past but are not currently treated; or on ADHD medications but finding them inconvenient (due to short duration of action) or not very helpful
Who cannot join
- Children and parents/guardians who do not understand or cannot follow necessary instructions; children and parents who are unwilling to comply with study procedures or cooperate with child psychiatrist.
- Children taking excluded medications.
- Children with history of intolerance to MPH/stimulant medications or no response to adequate stimulant trials.
- Children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders.
- Children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some ADHD symptoms.
- Children with screening abnormalities deemed clinically significant by child psychiatrist.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Insitute
New York, New York, 10032
About this study
Official title: Long-Duration Stimulant Treatment of ADHD in Young Children-Feasibility Study
This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.
Read the detailed description
This is a single site, open-label, four-week feasibility study of long-duration beaded methylphenidate (B-MPH), also known as Ritalin LA™. B-MPH is a FDA-approved medication for children 6 years and older with attention-deficit/hyperactivity disorder (ADHD), but there are no studies of its use in preschoolers. This study will evaluate the safety and effectiveness of B-MPH for ADHD treatment in 4-to-5-year old children.
Total study duration is approximately 5 weeks. It includes a screening evaluation and 4 weeks of B-MPH treatment with doses ranging from 10 to 30 mg (based on the individual tolerability and efficacy). The study doctor will conduct parent-training sessions during the treatment visits.
- Being tested
- B-MPH
- Keywords
- ADHD, Attention-deficit/hyperactivity disorder (ADHD)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-MPHDrug
Also called Ritalin LA
Dosage form is a 20 mg capsule to be given once daily in the morning for 30 days
| Study group | Role | What they receive |
|---|---|---|
| ADHD Treatment Group | Experimental | Single-arm, open-label, once-daily-dosing of long-duration beaded MPH (B-MPH) at 10-30 mg (flexible titration) in 4-to-5 year old children with ADHD. Receives: Drug: B-MPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)
The SNAP-IV Rating Scale is a revision of the Swanson, Nolan and Pelham (SNAP) Questionnaire (Swanson et al, 1983). The SNAP-IV is based on a 0 to 3 rating scale: Not at All = 0, Just A Little = 1, Quite A Bit = 2, and Very Much = 3. Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item, as shown for ratings on the ADHD-Inattentive (ADHD-I) subset.
Sub scale ranges from 0-3. Higher scores mean better outcome. Change score from baseline is reported.
Measured: week 5
Clinical Global Impressions-Severity (CGI-S)
CGI-S is designed to assess severity of illness on a seven-point scale: 1 = normal (not at ll ill) to 7 = among the most extremely ill patients.
Range: 0-7, higher score means worse outcome. Change from baseline is reported.
Measured: week 5
Children's Global Assessment Scale (C-GAS)
Children's Global Assessment Scale (C-GAS) is designed to assess overall functioning across settings. The scale is rated from 1 to 100, with lower scores reflecting poorer adjustment. Change from baseline is reported.
Measured: week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startMar 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurence Greenhill, New York State Psychiatric Institute
- Investigators
- Laurence L Greenhill, MD, Principal investigator, New York State Psychiatric Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257725
- Sponsor's protocol ID
- 4939
- Acronym
- B-MPH
- Status last verified
- Aug 2020
- First submitted
- 21 Nov 2005
- Last updated
- 26 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Maayan L, Paykina N, Fried J, Strauss T, Gugga SS, Greenhill L. The open-label treatment of attention-deficit/hyperactivity disorder in 4- and 5-year-old children with beaded methylphenidate. J Child Adolesc Psychopharmacol. 2009 Apr;19(2):147-53. doi: 10.1089/cap.2008.053.
PubMed 19374023
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Duration Stimulant Treatment of ADHD in Young Children-Feasibility Study
- ClinicalTrials.gov ID
- NCT00257725
- Acronym / sponsor ID
- B-MPH / 4939
- Keywords
- ADHD, Attention-deficit/hyperactivity disorder (ADHD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 23 Nov 2005 (estimated)
- Results
- Posted 26 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.
Detailed description
This is a single site, open-label, four-week feasibility study of long-duration beaded methylphenidate (B-MPH), also known as Ritalin LA™. B-MPH is a FDA-approved medication for children 6 years and older with attention-deficit/hyperactivity disorder (ADHD), but there are no studies of its use in preschoolers. This study will evaluate the safety and effectiveness of B-MPH for ADHD treatment in 4-to-5-year old children.
Total study duration is approximately 5 weeks. It includes a screening evaluation and 4 weeks of B-MPH treatment with doses ranging from 10 to 30 mg (based on the individual tolerability and efficacy). The study doctor will conduct parent-training sessions during the treatment visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD Treatment Group | Experimental | Drug: B-MPHSingle-arm, open-label, once-daily-dosing of long-duration beaded MPH (B-MPH) at 10-30 mg (flexible titration) in 4-to-5 year old children with ADHD. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Parents/guardians and children must speak English and/or Spanish; parents/guardians must sign consent form; children must verbally assent.
- Boys and girls from 4-5 years old (inclusive) at screening.
- Children who meet the DSM-IV criteria for a primary diagnosis of ADHD (combined or hyperactive subtype), with symptoms present for at least 9 months.
- Children who demonstrate adequate need for treatment due to ADHD symptom-severity and clinical impairment.
- Children with IQ of at least 70 confirmed by valid IQ test.
Key exclusion criteria (6 listed)
- Children and parents/guardians who do not understand or cannot follow necessary instructions; children and parents who are unwilling to comply with study procedures or cooperate with child psychiatrist.
- Children taking excluded medications.
- Children with history of intolerance to MPH/stimulant medications or no response to adequate stimulant trials.
- Children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders.
- Children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some ADHD symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-MPHAlso: Ritalin LADosage form is a 20 mg capsule to be given once daily in the morning for 30 days | Drug | ADHD Treatment Group |
Primary outcome
Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)
Time frame: week 5
The SNAP-IV Rating Scale is a revision of the Swanson, Nolan and Pelham (SNAP) Questionnaire (Swanson et al, 1983). The SNAP-IV is based on a 0 to 3 rating scale: Not at All = 0, Just A Little = 1, Quite A Bit = 2, and Very Much = 3. Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item, as shown for ratings on the ADHD-Inattentive (ADHD-I) subset. Sub scale ranges from 0-3. Higher scores mean better outcome. Change score from baseline is reported.
Clinical Global Impressions-Severity (CGI-S)
Time frame: week 5
CGI-S is designed to assess severity of illness on a seven-point scale: 1 = normal (not at ll ill) to 7 = among the most extremely ill patients. Range: 0-7, higher score means worse outcome. Change from baseline is reported.
Children's Global Assessment Scale (C-GAS)
Time frame: week 5
Children's Global Assessment Scale (C-GAS) is designed to assess overall functioning across settings. The scale is rated from 1 to 100, with lower scores reflecting poorer adjustment. Change from baseline is reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19374023Maayan L, Paykina N, Fried J, Strauss T, Gugga SS, Greenhill L. The open-label treatment of attention-deficit/hyperactivity disorder in 4- and 5-year-old children with beaded methylphenidate. J Child Adolesc Psychopharmacol. 2009 Apr;19(2):147-53. doi: 10.1089/cap.2008.053.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence L Greenhill, MD principal investigator
New York State Psychiatric Insitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing B-MPH in people with Attention Deficit Disorder With Hyperactivity, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swanson, Nolan, and Pelham Questionnaire (SNAP-IV) (time frame: week 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00257725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.